FDA label
What is Farxiga used for?
Farxiga contains dapagliflozin propanediol. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “FARXIGA (dapagliflozin) is indicated: To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression; To reduce the risk of CV death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure; To reduce the risk of hospitaliz...”
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Farxiga, tablet, film coated
Indications and Usage, quoted from the label by AstraZeneca Pharmaceuticals LP (NDA202293). Cross-references to other label sections are left out.
FARXIGA (dapagliflozin) is indicated:
- To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
- To reduce the risk of CV death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure.
- To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors.
- As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
Limitations of Use
- FARXIGA is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.
- FARXIGA is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. FARXIGA is likely to be ineffective in this setting based upon its mechanism of action.
- FARXIGA is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. FARXIGA is not expected to be effective in these populations.
Source: DailyMed label, set id 72ad22ae-efe6-4cd6-a302-98aaee423d69, version 49, effective June 3, 2026. NDC 0310-6205, one of 5 listings for this product.
Questions
What is Farxiga used for?
The FDA label says: “FARXIGA (dapagliflozin) is indicated: To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression; To reduce the risk of CV death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure; To reduce the risk of hospitaliz...”
What drug class is Farxiga?
FDA lists dapagliflozin propanediol in the Sodium-Glucose Cotransporter 2 Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Farxiga
- Is Farxiga a controlled substance?Federal schedule
- Generic for FarxigaFDA Orange Book
- What is Dapagliflozin Propanediol used for?FDA label uses
- Is Dapagliflozin Propanediol a controlled substance?Federal schedule
- Sodium-Glucose Cotransporter 2 Inhibitors listFDA drug class
- Farxiga Medicare Part D coverageBy plan and state
- NDC 0310-6205Farxiga NDC record
- NDC 0310-6210Farxiga NDC record
- NDC 50090-3481Farxiga NDC record